找回密码
 To register

QQ登录

只需一步,快速开始

扫一扫,访问微社区

Titlebook: Integrated Safety and Risk Assessment for Medical Devices and Combination Products; Shayne C. Gad Book 2019 Springer Nature Switzerland AG

[复制链接]
查看: 38268|回复: 50
发表于 2025-3-21 19:10:35 | 显示全部楼层 |阅读模式
书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products
编辑Shayne C. Gad
视频video
概述Identify and verify the most appropriate available data.As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest.As the dura
图书封面Titlebook: Integrated Safety and Risk Assessment for Medical Devices and Combination Products;  Shayne C. Gad Book 2019 Springer Nature Switzerland AG
描述.While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation..Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex..A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant(yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understan
出版日期Book 2019
关键词medical device toxicology; medical devices and combination products safety; device materials; biocompat
版次1
doihttps://doi.org/10.1007/978-3-030-35241-7
isbn_softcover978-3-030-35243-1
isbn_ebook978-3-030-35241-7
copyrightSpringer Nature Switzerland AG 2019
The information of publication is updating

书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products影响因子(影响力)




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products影响因子(影响力)学科排名




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products网络公开度




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products网络公开度学科排名




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products被引频次




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products被引频次学科排名




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products年度引用




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products年度引用学科排名




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products读者反馈




书目名称Integrated Safety and Risk Assessment for Medical Devices and Combination Products读者反馈学科排名




单选投票, 共有 0 人参与投票
 

0票 0%

Perfect with Aesthetics

 

0票 0%

Better Implies Difficulty

 

0票 0%

Good and Satisfactory

 

0票 0%

Adverse Performance

 

0票 0%

Disdainful Garbage

您所在的用户组没有投票权限
发表于 2025-3-21 23:05:19 | 显示全部楼层
Kandice M. Nappier MPH,Sherrie Smith MSuer. hat schon im Jahre 1850 ihr triadisches Alter erkannt und nennt den Erzkalk von Bleiberg Alpenkalk, identifiziert ihn gleichzeitig mit dem unteren Muschelkalk, während er den „Muschelmarmor“ im Hangenden und die Schiefer (den sogenannten „Lagerschiefer“) als oberen Muschelkalk bezeichnet. Verhä
发表于 2025-3-22 03:26:51 | 显示全部楼层
发表于 2025-3-22 08:06:57 | 显示全部楼层
Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation,hat does not depend on interaction with the body chemically or metabolically. In vitro diagnostics are which test samples taken from the body and radiologic contrivance (such as X-rays, ultrasound devices, MRIs and such), which use energy prom outside the body for either diagnostic or therapeutic pu
发表于 2025-3-22 12:12:40 | 显示全部楼层
发表于 2025-3-22 13:14:00 | 显示全部楼层
Considerations for Leachables and Extractables Testing,L) testing approaches for medical devices. Extractables are indicated as chemical compounds generated under aggressive, exaggerated experimental conditions, while leachables are chemical compounds expected to be present in a medical device under clinical use conditions. Key regulatory guidances have
发表于 2025-3-22 21:07:36 | 显示全部楼层
Where the Data Is and What Is It?,nsult in order to find the data necessary for the said assessment. This chapter will start with the online sources used to help identify compounds without proper names, then sources to find pertinent data. Sources include online and print, both free and paid.
发表于 2025-3-22 22:04:06 | 显示全部楼层
发表于 2025-3-23 02:04:10 | 显示全部楼层
发表于 2025-3-23 08:12:39 | 显示全部楼层
An Introduction to (Q)SAR with Respect to Regulatory Submissions,molecules. These methods are used to support pharmaceutical research and regulatory submissions. Primarily, (Q)SARs are used to predict the activity of untested chemicals based on structurally related compounds with known activity. The term (Q)SAR is often used to refer to predictive models, especia
 关于派博传思  派博传思旗下网站  友情链接
派博传思介绍 公司地理位置 论文服务流程 影响因子官网 SITEMAP 大讲堂 北京大学 Oxford Uni. Harvard Uni.
发展历史沿革 期刊点评 投稿经验总结 SCIENCEGARD IMPACTFACTOR 派博系数 清华大学 Yale Uni. Stanford Uni.
|Archiver|手机版|小黑屋| 派博传思国际 ( 京公网安备110108008328) GMT+8, 2025-5-18 22:18
Copyright © 2001-2015 派博传思   京公网安备110108008328 版权所有 All rights reserved
快速回复 返回顶部 返回列表